TABLE 3.

Overall summary of adverse events‐safety analysis set

AE category	AGB101 (N = 78) n (%) / Events	Placebo (N = 83) n (%) / Events	Overall (N = 161) n (%) / Events
TEAEs	53 (67.9) / 148	59 (71.1) / 232	112 (69.6) / 380
Treatment‐related TEAEs	9 (11.5) / 15	3 (3.6) / 5	12 (7.5) / 20
Serious TEAEs	13 (16.7) / 16	10 (12.0) / 12	23 (14.3) / 28
Treatment‐related serious TEAEs	0	0	0
TEAEs leading to drug withdrawal (with ‘adverse event’ as primary reason for early treatment termination)	6 (7.7) / 8	3 (3.6) / 3	9 (5.6) / 11
TEAEs leading to death	2 (2.6) / 2	0	2 (1.2) / 2

Abbreviations: AE, adverse event; TEAE, treatment‐emergent adverse event.